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Under certain circumstances, where patients may require access to medicines or medical devices that have not been approved for use in Australia by the Therapeutic Goods Administration (TGA), a medical practitioner may be granted authority (under section 19(5) of the Therapeutic Goods Act) to become an authorised prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients for a particular indication.
In order to grant authorised prescriber status, the TGA must be satisfied of the following:
In order to apply to the TGA to become an authorised prescriber, practitioners must be endorsed by a Human Research Ethics Committee, or, where they do not have access to an appropriate HREC, a relevant specialist college. When a practitioner in engaged in clinical practice in a hospital, the HREC of that hospital should provide the endorsement.
To apply to the St Vincent’s Hospital (Sydney) HREC for endorsement to apply to the TGA as an Authorised Prescriber, clinicians are required to submit the following:
For more information regarding the Authorised Prescriber scheme, including the TGA application form for authorised prescribers, please refer to the TGA website - Access to Unapproved Products.